What’s Happening in the Month Ahead: December 2017

Can Conference Save Orphan Drug Tax Credit?

Orphan drug developers will be watching closely in the next few days as the GOP’s tax reform package goes to conference committee. Congress has to reconcile differences between the Senate version, which cuts the orphan drug tax credit from 50% to 27.5%, and the House bill, which eliminates it completely. The Foundation Fighting Blindness (FFB) has joined with 90 other organizations in opposing the cuts.

Santen Has PDUFA Date for Uveitis Indication

The Food and Drug Administration this month could deliver a big present to Santen Pharmaceutical Co. on December 24 – which is a Sunday – the date the FDA set to complete its review of Santen’s new drug application (NDA) for intravitreal sirolimus for treatment of noninfectious posterior segment uveitis, per the Prescription Drug User Fee Act (PDUFA). The FDA could act before the year runs out. The agency accepted the NDA for the indication back in April.

HHS Nominee, Ophthalmologist’s Son,
May Get a Hearing

The Senate Finance Committee may hold a hearing this month on the nomination of Alex Azar II to replace Tom Price as secretary of Health and Human Services (HHS). Azar has a connection to ophthalmology: His father, an MD also named Alex Azar, is a retired ophthalmologist and founder of the Azar Eye Institute in Maryland, as well as a former instructor at Johns Hopkins University. Azar the younger, a lawyer, was president of Eli Lilly’s US affiliate before starting his own consulting firm, and was deputy HHS secretary under George W. Bush.

Mallinckrodt to Present at BMO Conference

Specialty pharma company Mallinckrodt Pharmaceuticals will present at the BMO Prescriptions for Success Healthcare Conference, December 14, at the Westin Grand Central New York. Executive VP and CFO Matthew Harbaugh and executive VP and CSO Steven Romano, MD, will represent the company in a fireside chat at 8 a.m. Eastern time.